Chronix Biomedical announced publication of a study that supports the utility of its serum DNA blood tests to predict clinical status and monitor disease activity and response to treatment in multiple sclerosis (MS). Chronix Biomedical uses proprietary technology to identify disease-specific genetic fingerprints based on the circulating DNA that is released into the bloodstream by damaged and dying cells.

A growing body of publications from Chronix and other researchers shows that this circulating DNA can be identified and analyzed to provide a diagnostic window into ongoing changes in the genome associated with specific diseases-changes that can be used to track the presence or absence of active disease.

This new study is the first to show that the Chronix approach can be used to monitor the clinical status of a chronic disease. The findings are published in the current online edition of the Journal of Molecular Diagnostics.

“These positive data further validate the premise underlying the Chronix approach, showing that the many genetic anomalies associated with active and stable relapsing-remitting MS can be detected by analyzing DNA fragments circulating in the blood serum,” said Mario Clerici, M.D., Chair of Immunology, Department of Biomedical Sciences and Technologies, University of Milano, Milan, Italy and a co-author of the study. “The prognostic value achieved in this study supports the ability of this new approach to help manage relapsing-remitting multiple sclerosis, potentially offering clinicians a new tool to easily assess which MS treatment options are most effective for their patients, as well as providing critical information that will facilitate development of the next generation of MS therapeutics."

In the study, researchers applied advanced analytical techniques developed by Chronix to identify genomic DNA fingerprints in the bloodstream of 28 MS patients known to have relapsing or stable disease as compared to 50 healthy volunteers. Researchers were able to distinguish the MS patients from the healthy volunteers and they also were able to use these circulating DNA fingerprints to differentiate periods of active disease attacks from the stable periods of disease remission characterizing relapsing-remitting MS, which affects about 85% of MS patients.

William M. Mitchell, M.D., Ph.D., Professor of Pathology at Vanderbilt University and a co-author of the study noted,” The data from this study suggests that the Chronix quantitative blood test provides a simpler, safer and more cost effective approach to assessing the activity of investigational new drugs for MS. Development of new MS drugs is currently complicated by the fact that disease status is monitored using dye-enhanced MRI scans that are expensive and are associated with occasional toxicities. In addition, they can only show neurological damage after it has occurred, while the Chronix approach provides a real time measure of disease activity.”

The newly published MS data follows earlier work that demonstrated the ability of Chronix’s serum DNA-based assays to diagnose mad cow disease and chronic wasting disease in live animals, conditions that until now could only be diagnosed using post-mortem biopsies. These successful studies in three neurological disorders suggest that when specialized nerve cells die, they leave behind unique DNA fingerprints characteristic of the cell of origin. Chronix researchers have figured out how to identify and apply these unique fingerprints to diagnose disease and monitor disease activity.

“These positive data further support the Chronix approach to detecting and monitoring diseases, including neurologic diseases such as MS,” said Howard Urnovitz, Ph.D., Chief Executive Officer of Chronix. “We are now preparing to offer laboratory testing services to support clinical trials for new neurologic drugs, initially focusing on MS and expanding to diseases such as Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease and autism. Eventually we intend to offer testing services that will allow physicians to monitor ongoing disease status and response to treatment in their patients with MS and other chronic neurological conditions.”

A publication in Molecular Cancer Research in March demonstrated the potential utility of the Chronix serum DNA assays in breast cancer. The findings demonstrated that the Chronix approach was able to detect invasive breast cancer with high diagnostic sensitivity and specificity, even at the earliest stage when tumors are very small.

Dr. Clerici is a member of the Chronix Medical Advisory Board and has an equity position in the company. Dr. Mitchell is an independent member of the Chronix Board of Directors and has an equity position in the company.